Bolsonaro government breaks law that would increase supply of drugs against Covid in Brazil

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Although Europe and the United States already have a wide supply of effective drugs against Covid-19, some of these drugs have not yet arrived in Brazil, such as Paxlovid and molnupiravir, which prevent the disease from worsening.

To change this scenario, the federal government could trigger a law considered one of the best in the world in terms of breaking pharmaceutical patents, which would allow the use of generics in the country. But there are only a few days left to apply this rule to Covid – and nothing indicates that this will happen.

Law 14,200 of 2021 was sanctioned by President Jair Bolsonaro (PL) in September last year, with vetoes, after being approved in the House and Senate. The rule facilitates so-called compulsory licensing — better known as “patent infringement” — during health emergencies. This mechanism temporarily suspends the exclusivity of a laboratory to produce and sell drugs, vaccines and tests, allowing other companies to import or develop generics.

When there is an emergency, as is the case with the pandemic, the law now requires the government to disclose within 30 days a list of products that may have their patent suspended. The Bolsonaro administration, however, did not comply with the measure, even with the shortage of medicines in the domestic market and the beginning of international production of generics. And the window for that to happen closes next Sunday (22), when the Public Health Emergency of National Importance expires — a declaration like this must be in force to apply the law.

“The government is breaking the law”, evaluates lawyer Francisco Viegas, from Doctors Without Borders (MSF). “Considering that we are still in an emergency and that there are already medicines against Covid in global terms, the government has an obligation to publish the list”, agrees lawyer Matheus Falcão, a health analyst at the Brazilian Consumer Institute (Idec).

Viegas lists another reason that forces the government to activate the law: unsatisfactory negotiations between the Ministry of Health and pharmaceutical companies, in which volume, price or term do not meet the country’s needs.

He cites the case of Pfizer’s Paxlovid, which should be sold to Brazil for US$ 250 (R$ 1,240) the treatment — with ten pills. Its generic version, however, will be priced at cost for 95 low- and middle-income countries, in an agreement made by Pfizer itself. “Internationally, there is a great demand for Paxlovid, but the delivery volume is small and there is no transparency in the contracts. We do not know the amount that Pfizer is offering to the Brazilian government, if they are reducing the volume due to a lack of supplies.”

The use of Paxlovid was authorized in March by Anvisa, for adults with mild and moderate conditions, but a high risk of becoming seriously ill – people with comorbidities, the elderly and immunosuppressed. In tests, the drug reduced the risk of hospitalization by 89%.

On the 6th, the Ministry of Health approved its inclusion in the SUS, but restricted the target audience to only the elderly and immunosuppressed. Sought by Repórter Brasil, the ministry did not comment on the negotiation or the breach of the law. Pfizer, on the other hand, said that it is able to provide “the amount that the ministry deems necessary” and that it has already forwarded a contract proposal to the government, but did not provide the details – see the note in full.

The legislation already allowed the breach of patents in emergencies, but as the Bolsonaro government did not move, dozens of proposals emerged in Congress to facilitate the process, presented by politicians from different parties. Senator Paulo Paim (PT-RS) prevailed, with amendments incorporated by the rapporteur Senator Nelsinho Trad (PSD-MS) and by Deputy Aécio Neves (PSDB-MG).

Although it united Congress, the issue gained opposition from the pharmaceutical industry. The sector worked to block the text, claiming that the bills would drive away foreign investment and make it difficult for vaccines to arrive in the country, which did not happen. Despite the sector having achieved important setbacks in the final text — above all, in Bolsonaro’s vetoes — the approved law brought advances.

One of the main ones was to set a deadline for the government to disclose the list of products that can have their patent suspended. “When the government has the freedom of time to do something, it ends up not having the obligation to do anything,” says Alan Rossi Silva, a lawyer with the Intellectual Property Working Group.

The new law also broke new ground by allowing compulsory licensing in patent applications. This makes it easier, since many products still do not have the patents granted, such as rendesivir, also indicated for Covid – due to its high price, it is only used in the private network in Brazil. The law also provides for the payment of royalties to technology owners, calculated at 1.5% of the generic sales value.

The text received wide approval. In the Chamber, he received 425 favorable votes — including government supporters such as deputy Eduardo Bolsonaro (PL-SP). All parties guided the benches to approve it, with the exception of Novo and the government leader, deputy Ricardo Barros (PP-PR), who was sought after by Repórter Brasil, but did not respond. In the Senate, there were 61 favorable votes.

‘Law lost strength’

Despite the consensus, the proposal had a fundamental opposition: Jair Bolsonaro. The president sanctioned the law, but vetoed sections considered fundamental by experts. He barred, for example, the autonomy of Congress to disclose the list of products subject to patent suspension, maintaining exclusivity with the Executive. He also vetoed the section that required pharmaceutical companies to transfer production know-how, as well as biological materials essential to manufacturing.

If it weren’t for Bolsonaro’s vetoes, Congress could already have released the list and the process would be on its way. “The veto prevents quick access to medicines or supplies that depend on the sharing of biological material”, says Trad. “Without this, it practically makes the production of vaccines and medicines unfeasible”, says Paim.

Access to these biological inputs is essential to reproduce vaccines with innovative technologies, such as mRNA, used in doses of Pfizer and Moderna, but which Brazil still does not know how to produce.

Deadline expired

Congress had 30 days to confirm or override the vetoes, but has not yet done so. “Eight months have passed and Congress has not taken action. As of May 22, another issue dies”, laments researcher Jorge Bermudez. “They treat the issue as if the pandemic had ended”, says Viegas.

Who sets the vetoes for voting is the president of the Senate, Rodrigo Pacheco, who was contacted by the report, but did not respond. The topic has already been included seven times on the agenda. “Each time they put it to a vote, the movement of pressure grows so that the veto is overturned”, says Paim, who summarizes the impasse. “Despite the majority of the government and the drug lobby, senators don’t want to keep this veto in an election year because it would be a vote for death and against vaccines and drugs.”

When the government does not comply with the law, Brazilians are left without access to useful medicines to face a pandemic that has not yet ended, explains Débora Melecchi, from the pharmaceutical commission of the National Health Council. “Even with the end of the health emergency, there are millions of Brazilians with serious sequelae from Covid and who will continue to need new pharmaceutical technologies.”

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